Cohesivity of hyaluronic acid fillers: Development and clinical implications of a novel assay, pilot validation with a five-point grading scale, and evaluation of six US food and drug administration-approved fillers

Hema Sundaram, Rod J. Rohrich, Steven Liew, Gerhard Sattler, Sergio Talarico, Patrick Trévidic, Samuel Gavard Molliard

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Background: Biophysical characteristics of hyaluronic acid gel fillers reflect individual manufacturing processes. They confer rheologic properties that provide scientific rationale with Evidence Level II clinical correlation for selection of appropriate fillers for specific clinical applications. Cohesivity, a key property, maintains gel integrity, contributes to tissue support with natural contours, and diminishes surface irregularities. In this publication, a new, standardized visual assay for hyaluronic acid cohesivity is presented, applied, and discussed. Methods: Colored hyaluronic acid gel specimens were automatically extruded under standardized conditions into sterile water stirred at a constant rate. Based on 90 digital images showing ratios of intact to dispersed gel during assay of 10 Communauté Européenne-marked fillers, the five-point visual Gavard-Sundaram Cohesivity Scale was developed. Six plastic surgeons and dermatologists performed pilot validation of the scale, subsequently used to evaluate six U.S. Food and Drug Administration-approved fillers. Results: Validation of the Gavard-Sundaram Cohesivity Scale showed substantial repeatability and interrater consistency. Mean cohesivity scores from three assays of each tested filler showed significant differences. Cohesivity was high for Cohesive Polydensified Matrix (Belotero Balance), medium-high for Hylacross (Juvéderm Ultra 2/Ultra XC and Ultra 3/Ultra Plus XC), low-medium for Vycross (Juvéderm Voluma), and low for non-animal-stabilized hyaluronic acid (Restylane and Perlane). Conclusions: An evidence-based approach requires clinical corroboration of in vitro data. This new, reproducible cohesivity assay may have value together with elasticity (G') and viscosity measurements to understand and leverage distinct tissue distribution patterns and clinical behaviors of different hyaluronic acid products.

Original languageEnglish (US)
Pages (from-to)678-686
Number of pages9
JournalPlastic and Reconstructive Surgery
Volume136
Issue number4
DOIs
StatePublished - Oct 1 2015

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Hyaluronic Acid
United States Food and Drug Administration
Gels
Elasticity
Tissue Distribution
Viscosity
Water

ASJC Scopus subject areas

  • Surgery

Cite this

Cohesivity of hyaluronic acid fillers : Development and clinical implications of a novel assay, pilot validation with a five-point grading scale, and evaluation of six US food and drug administration-approved fillers. / Sundaram, Hema; Rohrich, Rod J.; Liew, Steven; Sattler, Gerhard; Talarico, Sergio; Trévidic, Patrick; Molliard, Samuel Gavard.

In: Plastic and Reconstructive Surgery, Vol. 136, No. 4, 01.10.2015, p. 678-686.

Research output: Contribution to journalArticle

Sundaram, Hema ; Rohrich, Rod J. ; Liew, Steven ; Sattler, Gerhard ; Talarico, Sergio ; Trévidic, Patrick ; Molliard, Samuel Gavard. / Cohesivity of hyaluronic acid fillers : Development and clinical implications of a novel assay, pilot validation with a five-point grading scale, and evaluation of six US food and drug administration-approved fillers. In: Plastic and Reconstructive Surgery. 2015 ; Vol. 136, No. 4. pp. 678-686.
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AU - Rohrich, Rod J.

AU - Liew, Steven

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AU - Talarico, Sergio

AU - Trévidic, Patrick

AU - Molliard, Samuel Gavard

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